FDA Adverse Event
Other
Summary report: N
TREATMENT RECLINER
MDR report key: 1869058
·
Received October 7, 2010
Report
- Report Number
- 1831750-2010-02708
- Event Type
- Other
- Date Received
- October 7, 2010
- Date of Event
- September 8, 2010
- Report Date
- September 14, 2010
- Manufacturer
- STRYKER CORP, MEDICAL DIVISION
- Product Code
- FRK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: IT WAS DETERMINED THAT THE FOOT REST ELEVATION AND BACK REST RECLINE FUNCTIONS WERE BEING ACTIVATED AT THE SAME TIME. THIS WAS CAUSING THE FOOT REST TO ELEVATE RAPIDLY. THE NURSING SUPERVISOR HAS BEEN EDUCATED ON THE PROPER USE OF THE RECLINER, THE BACK REST MUST BE UPRIGHT (VERTICAL) BEFORE ELEVATING THE FOOT REST.
Description of Event or Problem · 1
IT WAS REPORTED THE LEG SECTION WAS RELEASING TOO QUICKLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TREATMENT RECLINER | EXAMINATION AND TREATMENT CHAIR | FRK | STRYKER CORP, MEDICAL DIVISION | 3500000710 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |